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For Patients User Guide for patients CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use. IMPORTANT USER INFORMATION Review the product instructions before using the Bios device. Instructions can be found in this user manual. Failure to use the Bios device and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in injury associated with misuse of device. Manufacturer information GraphWear Technologies Inc. 953 Indiana Street, San Francisco CA 94107 Website: www.graphwear.co Email: [email protected] 1 Table of Contents Safety Statement 4 Indications for use 4 Contraindication 5 No MRI/CT/Diathermy - MR Unsafe 5 Warnings 5 Read user manual 5 Don’t ignore high/low symptoms 5 Don’t use if… 5 Avoid contact with broken skin 5 Inspect 6 Use as directed 6 Check settings 6 Where to wear 6 Precaution 7 Avoid sunscreen and insect repellant 7 Keep transmitter close to display 7 Is It On? 7 Keep dry 8 Application needs to always remain open 8 Device description 8 Purpose of device 8 What’s in the box 8 Operating information 11 Minimum smart device specifications 11 Android 11 iOS 12 Installing the app 12 Setting up Bios devices 32 Setting up Left Wrist (LW) device 32 Setting up Right Wrist (RW) device 42 Setting up Lower Abdomen (LA) device 52 2 Confirming that all devices are connected 64 Removing the devices 65 Removing the sensors 67 How to charge the transmitter 69 Setting up and using your Self Monitoring Blood Glucose (SMBG) meter 78 Inserting blood values into the application 79 Inserting meal and exercise information 85 Inserting medication information 89 Change sensor 92 Providing feedback 98 Troubleshooting information 101 What messages on your transmitter display mean 101 FAQ? 102 I need to access the FAQ from my app 102 I am unable to install the mobile application on my smart device. What should I do? 102 My transmitter is not ON 103 My transmitter will not connect 103 My app notified me that my transmitter has disconnected 103 My transmitter shows ‘Data uploading’ 103 My transmitter shows ‘Open indicate’ 104 What if I lost my phone? 104 My phone ran out of battery 104 What is the QR code on the top left of my app? 104 What is the “?” on the top right of my app? 105 On my Android phone, when I click “Capture”, the app doesn’t take a picture of my SMBG 105 When I wear my devices again and try to connect, the device screen shows a six digit passkey 105 User assistance information 105 Appendix 106 Appendix A - Compatible smart devices 106 Android devices 106 iOS devices 118 3 Safety Statement What is a Safety Statement A Safety Statement is a brief statement of the Bios device indications, contraindications (when to avoid using it), relevant warnings, and precautions. The Safety Statements are meant to keep you and the Bios device safe while using it: 1. Indications How, for what purposes, and under what circumstances you should use the Bios device. Indications let you know who should use the Bios device and when. 2. Contraindication Contraindications let you know when not to use the Bios device. If used during these situations, you may hurt yourself or the Bios device and the risk of use clearly outweighs the benefit. 3. Warning Important hazard information: Describes serious or life- threatening circumstances to stay away from while using the device, their consequences, and how to avoid danger. 4. Precaution Special steps you need to take while using the device preventing minor or moderate injury to either you or the device. Indications for use Investigational device. Limited by Federal (or United States) law to investigational use only. If a medical emergency occurs, please contact 911. 4 Contraindication No MRI/CT/Diathermy - MR Unsafe Don’t wear your Bios device (sensor, transmitter, receiver, or smart device) for magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The Bios device hasn’t been tested in those situations. The magnetic fields and heat could damage the components of the Bios device, which may cause it to display inaccurate Bios sensor glucose readings (Bios device readings) or may prevent alerts. Warnings Read user manual Before you use the Bios device, please read all associated materials or you will not use it correctly. Don’t ignore high/low symptoms The Bios device will not indicate any information regarding your glucose levels. Please use approved devices to make decisions. Use your blood glucose meter (SMBG) to make diabetes treatment decisions or, if needed, seek immediate medical attention. Don’t use if… Do not use the Bios device if you are pregnant, on dialysis, or critically ill. Avoid contact with broken skin Do not wear the Bios device on top of broken skin. If irritation or reaction occurs, immediately contact your health care professional. 5 Inspect Don’t use a damaged or cracked Bios device transmitter. A damaged Bios device transmitter could cause injuries from electrical shocks and may make the Bios device not work correctly. Use as directed The Bios transmitter and sensor is small and may pose a choking hazard. Don’t put it in your mouth or let children hold it without adult supervision. Check settings Notifications: When using your smart device, you should confirm that your volume is turned up, your phone is not muted, and you do not have headphones plugged in. If your volume is not turned up, the device is muted, or headphones are plugged in, you will not hear the sound of any notifications, including important alarms. Bluetooth: Your Bios transmitter talks to your app via Bluetooth. Make sure your smart device Bluetooth is on. If not, you will not get alarm/alerts or CGM information. Battery: The GraphWear patient application must always be running in the background and may drain your smart device battery. Keep the battery charged. Where to wear All patients will be required to wear Bios devices on 3 different locations: right wrist (RW) seen at location 1, left wrist (LW) seen at location 2, and lower abdomen (LA) seen at location 3. 6 Precaution Avoid sunscreen and insect repellant Some skin care products, such as sunscreens and insect repellents, can make the plastic used in your Bios device crack. Before using your Bios device, make sure there are no cracks in your transmitter. If you find a crack, please contact Technical Support. Do not allow these skin care products to contact your Bios device. After using skin care products, wash your hands before touching your Bios device. If any skin care products get on your Bios device, immediately wipe with a clean cloth. Keep transmitter close to display Keep your Bios transmitter and smart device within 20 ft with no obstacles (like walls or metal) between them. Otherwise, they might not be able to communicate. Is It On? If the receiver or smart device is turned off (shut down), it will not show any alarm/alerts. Make sure your display device is turned on. 7 Keep dry Make sure that the Bios device does not get wet. If liquid of any kind slides under the transmitter and onto the sensor, please remove the device from skin, remove the sensor, and let it dry for 30 minutes before rewearing. Application needs to always remain open Please ensure that your mobile application on your smart device is never closed. If it is closed, immediately reopen the application to ensure that the integrity of the data is maintained. Device description Purpose of device The purpose of the Bios device is to create a needle and pain free diabetic monitoring experience. The current version is for investigational use to ensure that the readings from the Bios device match currently used devices to ensure accuracy. What’s in the box The Bios device comes with two boxes. The boxes contain the following BIOS DEVICES COMPONENTS # Provided Transmitter x 3 8 Charger x 3 Charging cable x 3 Wall charger x 1 Sensor x 9 9 Band x 2 Pre-attached to transmitter Patches x 4 COMMERCIALLY AVAILABLE ACCESSORIES # Provided Self Monitoring Blood x 1 Glucose (SMBG) meter kit Self Monitoring Blood Glucose (SMBG) strips x 1 Self Monitoring Blood Glucose (SMBG) lancets x 1 10 Transmitter: The transmitter houses the replaceable sensor and sends the glucose information to the application on the smartphone. Device charger: The charger is used to charge the transmitter battery. For best results, recharge the transmitter between each use to ensure full transmitter battery life. Charging cable: The charging cable is used to plug the transmitter into the provided wall charger. Wall charger: The wall charger is used to plug the chargers into a wall outlet to charge all three devices at once. Sensor: The sensor measures glucose and conveys that information to the transmitter Band: Holds the transmitter with inserted sensor in place when worn as a watch on the wrist. Patch: Holds the transmitter with inserted sensor in place when worn on-body (e.g., abdomen). Self Monitoring Blood Glucose (SMBG) meter: Provided for subject convenience to use during the trial Self Monitoring Blood Glucose (SMBG) strips: Provided for subject convenience to use during the trial. Operating information Minimum smart device specifications To use the Bios device, you need a smart device that meets the following specifications. You will find a comprehensive list of almost all compliant devices below. Smart device must have at least 100MB free space throughout the course of the trial. Smart device must have access to an internet connection, either WiFi or mobile data (2G, 3G, LTE, etc), at least once every 3 hours throughout the course of the trial.
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